moberg pharma ab -...
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Investor presentation, February 19, 2015Anna Ljung, CFO
Moberg Pharma ABProviding Unique Products in Underserved Niches throughCommercial and Innovation Excellence
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Disclaimer
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Statements included herein that are not historical facts are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, Moberg Pharma’s results could be materially affected. The risks and uncertainties include, but are not limited to, risks associated with the inherent uncertainty of pharmaceutical research and product development, manufacturing and commercialization, the impact of competitive products, patents, legal challenges, government regulation and approval, Moberg Pharma’s ability to secure new products for commercialization and/or development and other risks and uncertainties detailed from time to time in Moberg Pharma’s interim or annual reports, prospectuses or press releases.
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2014 TV commercial in the Nordics
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Strategic elements
Growth strategy- Organic growth- M&A/Innovation engine
Build value through combiningBrand/IP Equity
Strong focus on shareholder valueand achieving EBITDA target
Vision
Build a leading niche player in strategic focus areas, such as:- Topical Foot Care/Dermatology- Topical Pain Management- Additional areas to be added
No 1 in Onychomycosis in keyregions
Financial goal
25% EBITDA margin with healthygrowth from 2016
Moberg PharmaPROVIDING UNIQUE PRODUCTS IN UNDERSERVED NICHES
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Net Sales grew to 185 MSEK ($25m, TTM)- U.S. OTC Sales operations- Products sold in 40+ countries- 30 employees in Stockholm and NJ
Focus in OTC/Dermatology/Topicals- Leading U.S. OTC SKU in Nail Fungus- Superior PII data for MOB015
3 acquisitions in last 24 months- Nov 2012, Alterna LLC - Dec 2013, OTC brands from Bayer - Apr 2014, BUPI, Ph ll for oral pain relief
Market Cap 600 MSEK ($ 75m) (OMX:MOB)
Moberg PharmaPROVIDING UNIQUE PRODUCTS IN UNDERSERVED NICHES
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18 consecutive quarters of Sales growth
Product Sales, TTM, MSEK
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0
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40
60
80
100
120
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160
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Q110 Q210 Q310 Q410 Q111 Q211 Q311 Q411 Q112 Q212 Q312 Q412 Q113 Q213 Q313 Q413 Q114 Q214 Q314
MSEK
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Rapid growth in Net Sales and EBITDA
6NOTE: Commercial EBITDA does not include R&D and Business Development expenses for future products outside existing brands, e.g. Phase II assets
Net Sales, MSEK
156 (+29%)
121
34 (+240%)
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-10
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EBITDA, MSEK EBITDA Commercial Operations, MSEK
Jan – Sep 2013Jan - Sep 2014
Neg 14% 9% 22%
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Majority of revenue from direct OTC sales, RoW growth starting to pick up
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Sales via distributors
29%
Direct OTC Sales 71%
Other13%
Nalox/ Kerasal Nail
58%
Kerasal15%
JointFlex14%
RoW7%
Europe 18%
Americas 75%
Channels Products Geography
Distribution of revenue, Jan – September 2014
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Building a profitable growth portfolio of Brands, Products and Projects through M&A and internal development
Current portfolio Future portfolio
Brands
Products sold through partners
15 partners inclMeda, Menarini & Paladin
Pipeline
®
®
MOB-015
BUPI
X Y Z+
X Y+8
Commercial Operations
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U.S. retail sales of Kerasal Nail increased 31% in Q314
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Q3 2013 Q3 2014
Kerasal Nail™ – U.S. market share1)No 1. SKU in the U.S. From 0 23%
market share in 3 years
Available at all major retailers >30 000 stores
On Top-50 list of ”Most Innovative New Products”- Drug Store News, 2012
Three clinical studies supporting efficacy and safety (n = ca 600)
1)Retail sales of nail fungus products excluding private label in Multioutlet Stores over the last 52 weeksending September 7, 2014 as reported by SymphonyIRI
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Efficient infrastructure for building OTC brands in the U.S.
Retailers/WholesalersSales ForceCMOs
Logistics
Sales and marketing/Brand Management
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Emerson Healthcare
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Ten largest retailers account for almost 70% of sales
U.S. OTC market is highly consolidated
Source: IRI. 52 weeks as of May 2013
+4.5%+3.2%+4.9% +5.2%
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Organic growth YTD (Value), %
5%
17%
U.S. OTC market Moberg U.S.
Outperforming the market through combining Brand and IP equity
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Strategic brands
• Kerasal® - Foot careEmtrix®
• Domeboro® - Derma/Skin irritation
Mature brands
• Jointflex® - Ext. analgesic
• Vanquish® - Int. analgesic
• Fergon® - Iron supplement
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Acquisition of three cash-generating brands from Bayer Healthcare in Dec 2013
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• Noncore to Bayer Healthcare – no marketing in over 10 years, ca 3m$ in Net Sales
• Leverages U.S. OTC platform• Domeboro is a astringent solution that provides fast,
soothing itch relief for skin irritations• Vanquish provides strong headcache relief with lower
safety risk profile vs. competitors• Fergon is a high potency iron supplement• High loyalty brands on market 50+ years• Opportunity
• Targeted niche marketing to increase sales• Improve gross margin• Expand distribution
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Vanquish – Launched integrated Marketing plan
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Domeboro - Brand modernizationCONFIDENTIAL
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New web - Skin Care Center
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Moberg Pharma Global Markets –>20 markets remain to launch under current contracts
All markets
Jointflex Kerasal
Kerasal Nail/Nalox/Emtrix
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Distributor Sales well positioned for further growth
Note: Four largest distributors only, not an all inclusive list.
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1)CDH units, IMS. Market share of OTC and Rx products for onychomycosis.
Nalox™/Kerasal Nail®
Sales in >40 markets
Stronger claims recently approved Potential for further growth
Strong sales in Canada as response to launch of consumer advertising, Market leader with >50% of OTC sales (value) and 30% of all Rx/OTC units1)
Preparations for launches in China and SE Asia progressing well Malaysia 1st launch in Nov 2014 Large potential for 2015 and beyond
Det går inte att v isa bilden för tillfället.
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Asian launch initiated in Malaysia under our Emtrix® brand
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2014 H2 TV commercial in Malaysia
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Distribution in >1000 pharmacies in Malaysia (97%)
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Counter Top
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Window stickers in pharmacy
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Pharmacy training
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Pipeline assets
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Pipeline assets in phase II -Building on Topical drug delivery know how and IP portfolio
Pipeline asset
Indication StatusPeak sales potential, m$ USP
MOB-015 Onychomycosis Phase IIcompleted
250-500 Topical terbinafine with fast visible improvement and superior cure rates
BUPI Oral Mucositisand oral pain
Phase IIstarted
50-100 Lozenge formulation with effective pain relief for 2-3 hrs(vs 0,5 hrs for competition)
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Well tolerated
MOB-015Excellent Phase II results
Source: Moberg Pharma data on file, MOB-015 phase II study
MYCOLOGICAL CURE AT 15 MONTHS*
MYCOLOGICAL CURE AND EXCELLENT CLINICAL IMPROVEMENT OR CURE**
Study design Open label, n=25,
24 patients completed Once daily for 48w
Last follow-up at 60w Severely affected nails,
60% mean nail involvement
* 54% of patients completing the treatment (13 of 25), 52% of FAS (13 of 24) and 60% of PPAS** Means 10% or less clinical involvement
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Phase II results indicate that MOB015 has potential to become best in class (topical drug for Onychomycosis)
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Mycological cureActive Product Company Form at 6 months at 12/15
monthsComment
Terbinafine MOB-015 Moberg Pharma Topical 40%1) 54% 25-75% affected*
Efinaconazole Jublia Valeant Topical - 54% 20-50% affected**
Tavaborole Kerydin Anacor/Sandoz Topical - 31-36% 20-60% affected
Ciclopirox Penlac Valeant Topical - 29-36%2) 20-65% affected
Amorolfin Loceryl Galderma Topical - n/a3)
Terbinafine Lamisil Novartis Oral 40%4) 75%4)
Itraconazole Sporanox J&J Oral 25-30%4) 40-50%4)
Source: 1)Moberg Pharma data on file from ongoing phase II study; 2) Gupta AK, Fleckman P, Baran R. Ciclopirox naillacquer topical solution 8% in the treatment of toenail onychomycosis. J Am Acad Dermatol 43(4 Suppl):S70-80 (2000 Oct); 3) Mycological cure rates have not been published for Loceryl using the standard definition, which is the combination of negative fungal culture and KOH microscopy; 4) Double blind, randomized study of continousterbinafine compared with intermittent itraconazole in the treatment of toenail Onychomycosis, BMJ 1999;
*Mean affected nail area was 60%**Mean affected nail area was 36%
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Rationale for the superiority of MOB-015
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54% mycological cure, in patients with severe onychomycosis (60% mean involvement) Excellent clinical improvement, full photo documentation High terbinafine levels in patients:
- In nail bed: 45 µg/g (median value) 40x Oral TBF - In nail: 1610 µg/g (median value) 1000x Oral TBF
Safe – low plasma levels of TBF 1/1000 Oral TBF A reasonable assumption is that a Phase III strategy to include patients with only
20-50% nail involvement, will increase mycological and clinical cure rates, supported by:– Experience from previous trial with K101 (Nalox) (n=493) indicated a 40% higher
mycological cure rate in stratum with 25-50% affected nail area (27,1%) vs stratum with 50-75% affected nail area (19,1%).
– In the MOB-015B trial: Significantly higher myc cure (70%) in the 10 patients with<60% affected nail area (post-hoc analysis)
If significant clear nail growth is observed, it is obvious that complete cure rates increase in a stratum with less affected nail area
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Example of successful treatment with MOB-015
Before After
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Example of successful treatment with MOB-015
Before After
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Example of successful treatment with MOB-015
Before After
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MOB-015 – Next steps
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Dual track – Discussion with industrial/financial partners ongoing Refine Ph III program and CMC preparations
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BUPI – Long-acting lozenge with bupivacaine- Phase II started Oct 2014
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Product & Indication Bupivacaine lozenge for oral pain relief (mouth and throat) 1st indication: Oral Mucositis in cancer patients. Large unmet need Other indications: Burning Mouth Syndrome, Sjögren’s syndrome, Upper
gastrointestinal endoscopy.
Phase II study started – data expected summer 2015 Up to 40 patients in radiation therapy for Head-Neck Cancer Controlled study – Standard pain treatment with/without BUPI lozenge VAS scale Target: Demonstrate 2-3 hours of pain relief and superior to control
Team
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Management and Board with strong track recordManagement experienceMcKinsey, AZ, Q-Med, Biogen Idec, Insight, Pfizer
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Anna LjungCFO Thomas Thomsen Torbjörn Koivisto
Board experiencePharmacia/Pfizer, Lundbeck, Genmab, Quintiles, J&J, Barrier Therapeutics, NCH
Peter WolpertCEO and Founder
Mats Pettersson (Chair)
Wenche Rolfsen Geert Cauwenbergh
Kjell RensfeldtVP R&D
Martin IngmanVP Sales & marketing, ROW
Jeff VernimbGM North America
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Increasing high quality institutional investors (SW, US, FR)
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Shareholders No of shares Capital and votes, %ÖSTERSJÖSTIFTELSEN 2 245 179 16,1HANDELSBANKEN FONDER 834 477 6,0JPM CHASE NA (Altaris Capital Partners) 825 652 5,9FÖRSÄKRINGSAKTIEBOLAGET, AVANZA PENSION 798 417 5,7GRANDEUR PEAK 720 680 5,2TREDJE AP-FONDEN 656 000 4,7WOLCO INVEST AB (Peter Wolpert, CEO) 600 000 4,3SIX SIS AG, W8IMY 580 386 4,2GOLDMAN SACHS INTERNATIONAL LTD, W8IMY 512 419 3,7BANQUE CARNEGIE LUXEMBOURG S A (FUNDS) 326 494 2,3DEUTSCHE BANK AG LDN-PRIME BROKER, AGE FULL TAX 281 633 2,0SOCIETE GENERALE 258 621 1,9STATE STREET BANK & TRUST COM, BOSTON 225 000 1,6ML, PIERCE, FENNER & SMITH INCH 172 414 1,2SYNSKADADES STIFTELSE 172 201 1,2AB TRACTION 165 000 1,2MATTSSON, MICHAEL 154 708 1,1J P MORGAN CLEARING CORP, WP 149 896 1,1LUNDMARK, ANDERS 135 000 1,0DEUTSCHE BANK AG, LONDON BRANCH, W-8BEN 133 396 1,0SUMMA, 20 STÖRSTA ÄGARNA 9 947 573 71,2Övriga aktieägare 4 014 964 28,8TOTAL 13 962 537 100
Source: Euroclear Sweden AB per 2014-09-30
Stock options to Management
Outstanding stock options correspond to 8.1% of shares (6% to Management/Employees)
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Focus next 12 monthsPROVIDING UNIQUE PRODUCTS IN UNDERSERVED NICHES
Drive growth and EBITDA improvements
Fuel strong U.S growth- K-Nail and Neurocream launch- Line extensions and new SKUs
Grow Distributor Sales- EU: Extended indication- Launches in China/SE Asia, Mena
BD/Innovation Engine- M&A focus on US OTC products- MOB-015 partnering/ Phase III preparations- BUPI: Pll study, pursue sales as unlicensed
drug/partner and Orphan Drug designation